LifeFlow Rapid Infusion System FG5001

GUDID B355FG50011

Rapid Infusion system including handle and sterile tubing set SA5101

410 MEDICAL INNOVATION, LLC

Intravenous administration tubing extension set Intravenous administration tubing extension set

• Primary Device ID: B355FG50011
• NIH Device Record Key: 33a2e44a-4544-43e1-8bdb-f9c4de94bf11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeFlow Rapid Infusion System
• Version Model Number: FG5001
• Catalog Number: FG5001
• Company DUNS: 050212206
• Company Name: 410 MEDICAL INNOVATION, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B355FG50011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153731

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-31
• Device Publish Date: 2017-04-11

On-Brand Devices [LifeFlow Rapid Infusion System]

• 00860000288606: Rapid IV infusion system including handle with sterile tubing set SA5110
• B355FG50011: Rapid Infusion system including handle and sterile tubing set SA5101